Case C‑760/21

Kwizda Pharma GmbH

v

Landeshauptmann von Wien

(Request for a preliminary ruling from the Verwaltungsgericht Wien)

Judgment of the Court (Second Chamber) of 2 March 2023

(Reference for a preliminary ruling – Food safety – Food – Regulation (EU) No 609/2013 – Article 2(2)(g) – Concept of ‘food for special medical purposes’ – Other particular nutritional requirements – Nutritional requirements – Modification of the diet – Nutrients – Use under medical supervision – Ingredients not absorbed or metabolised in the alimentary canal – Distinction in relation to medicinal products – Distinction in relation to food supplements)

1. Approximation of laws – Food safety – Regulation No 609/2013 – Food for special medical purposes – Medicinal product for human use – Directive 2001/83 – Medicinal product – Concepts – Criteria

   (European Parliament and Council Regulation No 609/2013, Art. 2(2)(g); European Parliament and Council Directive 2001/83, Art. 1(2))

   (see paragraphs 28-31, 36, operative part 1)

2. Approximation of laws – Food safety – Regulation No 609/2013 – Food for special medical purposes – Nutritional requirements – Concept – Needs caused by an illness, disorder or health condition that must be met from a nutritional point of view – Included – Food for special medical purposes – Classification – Condition

   (European Parliament and Council Regulation No 609/2013, Art. 2(2)(g); Commission Regulation 2016/128, recital 3)

   (see paragraphs 41-43, 46-49, 52, operative part 2)

3. Approximation of laws – Food safety – Regulation No 609/2013 – Food for special medical purposes – Nutrient – Concept

   (European Parliament and Council Regulations No 1169/2011, Art. 2(2)(s) and No 609/2013, Art. 2(2)(g); Commission Regulation 2016/128, Art. 5(1))

   (see paragraphs 58, 59, 61-64, 66, operative part 3)

4. Approximation of laws – Food safety – Regulation No 609/2013 – Food for special medical purposes – Use under medical supervision – Condition – Classification as a food for special medical purposes – Condition

   (European Parliament and Council Regulation No 609/2013, Art. 2(2)(g) and 9(6); Commission Regulation 2016/128, recital 4)

   (see paragraphs 68, 74, 77, 81, operative part 4)

5. Approximation of laws – Food safety – Regulation No 609/2013 – Food for special medical purposes – Concept – Directive 2002/46 – Food supplements – Concept

   (European Parliament and Council Regulation No 609/2013, Art. 2(2)(g); Directive of the European Parliament 2002/46, Art. 2(a))

   (see paragraphs 84-86, 93, operative part 5)

See the text of the decision.